Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

NCT ID: NCT01834716

Last Updated: 2019-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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Researchers are trying to determine if cognitively normal subjects undergoing a moderate aerobic exercise program will accumulate less amyloid-ß (Aβ) concentration in their brain than subjects undergoing a non-aerobic exercise program, and further evaluating the safety and imaging characteristics of florbetapir F 18, the radioactive drug that will allow us to image changes in the brain amyloid-ß (Aβ).

Detailed Description

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After screening assessments have been completed, subjects will be randomized into one of two groups: aerobic exercise group and non-aerobic exercise group. All subjects will be trained on the Physical Activity Scale for the Elderly (PASE), using the Body Media armband, and exercise diary. Subjects will also complete an online food questionnaire.

Subjects assigned to the aerobic exercise group will work with an exercise trainer who will provide individual training (six half hour sessions) until they are proficient at the use of the equipment and understand goals. Subjects will return to Brooks Family YMCA at their convenience, but at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Subjects assigned to the non-aerobic exercise group will attend supervised classes on toning and stretching at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Conditions

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Alzheimer's Disease Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobics exercise

Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).

Group Type EXPERIMENTAL

Aerobic vs. Non-Aerobic exercise

Intervention Type BEHAVIORAL

Non-Aerobics Exercise

Participants in this group will be randomized to a non-aerobics (attending classes of toning and stretching a minimum of three times per week) exercise group.

Group Type EXPERIMENTAL

Aerobic vs. Non-Aerobic exercise

Intervention Type BEHAVIORAL

Interventions

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Aerobic vs. Non-Aerobic exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 65 years of age or older.
* Not diagnosed with memory problems.
* Do not exercise in which you sweat and/or raise your pulse rate more than 30 minutes two times per week.
* Able to walk ten blocks (about one mile).
* Willing to participate in weekly exercise classes at the Brooks YMCA for six months.
* Able to have an MRI and CT/PET scan.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Neill R. Graff-Radford, M.D.

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neill Graff-Radford, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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12-002817

Identifier Type: -

Identifier Source: org_study_id

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